Perioperative immune-checkpoint inhibition improves outcomes in muscle-invasive bladder cancer (MIBC). The phase III, randomized CA017-078 (ENERGIZE) trial evaluated perioperative nivolumab plus neoad...

Perioperative PD-(L)1 inhibitors, either combined with cisplatin-based chemotherapy or enfortumab vedotin, have improved outcomes in patients with muscle-invasive bladder cancer (MIBC) who are cisplat...

EFS and OS boost with ICI plus enfortumab vedotin in cisplatin-ineligible patients

Growth differentiation factor-15 (GDF-15) is overexpressed in muscle-invasive bladder cancer (MIBC) and was recently identified as a potential therapeutic…

Between 26 September 2023 and 26 March 2025, 50 patients were screened and 31 enrolled in GDFATHER-NEO at four centers in Italy. All had newly diagnosed MIBC of clinical stage T2–T4a disease; 19 of 31 (61%) had cT2 N0 M0 tumors. Twenty-two (71%) were male and 9 (29%) were female, consistent with the sex distribution of MIBC. High PD-L1 expression, defined as a locally assessed combined positive score (CPS) ≥10, was balanced between the two groups (8 of 15 (53%) in group A, receiving nivolumab plus placebo, and 9 of 16 (56%) in group B, receiving nivolumab plus visugromab). In total, 6 of 15 patients (40%) in group A and 5 of 16 (31%) in group B were ineligible for cisplatin because of impaired renal function or hearing loss; the remaining patients (9 of 15 (60%) and 11 of 16 (69%), respectively) declined cisplatin-based chemotherapy (Table 1). Within strata defined by clinical tumor stage and locally assessed PD-L1 expression, patients were allocated sequentially to three 4-weekly cycles of intravenous nivolumab 480 mg plus placebo (group A) or to three cycles of nivolumab 480 mg plus visugromab 20 mg kg−1 infused before nivolumab (group B); patients were blinded to their allocation...

An exploratory analysis of the phase 3 KEYNOTE-B15 trial found that ctDNA status was strongly prognostic for event-free survival regardless of treatment arm.

The KEYNOTE-866 trial did not meet its EFS primary end point with perioperative pembrolizumab added to neoadjuvant cisplatin and gemcitabine.

The European Commission approved pembrolizumab plus enfortumab vedotin for muscle-invasive bladder cancer, irrespective of cisplatin eligibility.

Reported Wednesday, Oct 21 - 6:46am EDT (TheFly subscription required to read more.)

(Adnkronos) - Msd ha annunciato oggi che la Commissione europea ha approvato pembrolizumab in combinazione con enfortumab vedotin, come trattamento neoadiuvante e successivamente, dopo cistectomia radicale, come trattamento adiuvante negli adulti con carcinoma della vescica muscolo-invasivo (Mibc) r

Natera社の血中循環腫瘍DNA（ctDNA）検査「Signatera」が、筋層浸潤性膀胱がん（MIBC）における術後アテゾリズマブ治療の適応判定用コンパニオン診断薬として、日本の医薬品医療機器総合機構（PMDA）から承認を取得した。

: To compare the efficacy and safety of three perioperative regimens for cisplatin-eligible muscle-invasive bladder cancer (MIBC) — enfortumab vedotin…